1. Field of the Invention
The present invention relates to dihydrate crystals of 4'-demethylepipodophyllotoxin 9-(4,6-O-ethylidene-2-dimethylamino-2-deoxy-.beta.-D-glucopyranoside (hereinafter referred to as etoposide-2-dimethylamino compound) hydrochloride having a potent carcinostatic activity. The present invention also relates to a process for production of etoposide-2-dimethylamino compound hydrochloride dihydrate crystals.
2. Description of the Prior Art
Etoposide-2-dimethylamino compound and its hydrochloride are disclosed in EP-A-0196618 [Japanese Patent Application KOKAI (Laid-open) No. 61-227590]. The compound has a potent carcinostatic activity and is expected to be effective as a carcinostatic agent.
However, the etoposide-2-dimethylamino compound and its hydrochloride are hygroscopic. In the case of the hydrochloride, there is a shortcoming that organic solvents such as acetone, methanol or the like which are used to form the hydrochloride remain (0.3 to 5%) in the crystals.
The remaining organic solvents become a problem when the etoposide-2-dimethylamino compound is used as a drug. The hygroscopic property also becomes a problem in designing medical preparations.